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Quality Assurance Specialist

Company: Pacific Pharmaceutical USA Inc.
Location: Rancho Cucamonga
Posted on: February 23, 2021

Job Description:

Job purposeA start-up Pharmaceutical company seeking a Quality Assurance specialist for their Pharmaceutical manufacturing facility in Inland Empire, California. The successful candidate will play a key role in implementing quality of Dietary supplements and OTC drug products in a manufacturing environment.Duties and responsibilitiesEnsure that products or services meet any federal, state or local government safety or quality standards.* Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality.* Draft quality assurance policies and procedures interpret and implement quality assurance standards.* Performing internal audits, evaluate audit findings and implement appropriate corrective actions.* Addressing nonconformities from previous internal and external audits.* Conducting a management review of the quality system.* Analyze data to identify areas for improvement in the quality system.* Following-up on and closing pending preventive and corrective action requests.* Insuring that organizational systems and training is in place.* Ensuring that documentation and design controls are appropriate for the organization.* Administering document control and configuration management system.* Overseeing established calibration and testing program.* Assisting the management team and provide QA support as necessary.* Investigate customer complaints and non-conformance issues* Maintaining design history file.Required Education and Experience:* BS degree in Pharmacy, Chemistry, Life Science or related discipline and a minimum of 5 years of relevant Quality compliance experience in Dietary supplement and OTC drug products.* Familiar with solid dosage pharmaceutical manufacturing process with thorough understanding in GMP, GLP, GCP.* Expertise in OTC products documentation as per 21CFR part211.* Experience in effectively managing FDA inspections and customer audits.SUCCESSFUL CANDIDATES MUST UPLOAD RESUMES

Keywords: Pacific Pharmaceutical USA Inc., Rancho Cucamonga , Quality Assurance Specialist, Other , Rancho Cucamonga, California

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